Comparative Study Between High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Oxygen desaturation index
研究概览
简要总结
This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop >4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.
详细描述
In the surgical setting, patients with obstructive sleep apnea (OSA) may have increased upper airway collapsibility affecting ventilation and increased sensitivity to sedation from anesthetics and opioids.
Surgical patients with OSA have a high risk for postoperative complications, including cardiac events, hypoxemia, and transfer to the intensive care unit . Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate to severe OSA , and effectively reduces the risk of cardiovascular events. Evidence has shown that CPAP effectively reduces length of ICU stay (LOS) in the postoperative setting. In these scenarios, conventional oxygen therapy and high-flow nasal cannula (HFNC) therapy have been used as an alternative for CPAP non-adherent patients.
HFNC delivers warm, humidified air through a nasal cannula at high flow rates of up to 60 L/min. This high flow rate may increase end-expiratory pharyngeal pressure up to 3 cm H2O, decreasing the force required to alleviate airway collapse . Using a nasal cannula interface in contrast to the CPAP mask may provide a more comfortable experience for patients during sleep .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group from 21 - 40 years old.
- •Both sexes.
- •Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than
- •OSA patients undergoing non cardiac surgeries.
- •Patients who will undergo scheduled elective surgeries under general anesthesia.
排除标准
- •Patient refusal of procedure or participation in the study.
- •Patients with severe OSA, STOP-BANG score more than or equal
- •Patients dependent on home ventilation CPAP or bilevel devices.
- •Pregnant females.
- •Post cardiac or thoracic surgery patients.
- •More than American Society of Anesthesiologists (ASA) II patients.
- •Head and face trauma patients.
研究组 & 干预措施
Conventional oxygen therapy group
Patients who will be randomized to simple oxygen mask therapy. The simple face mask will be applied in a rate range between 6-10 L/min.
干预措施: Conventional oxygen therapy group (Other)
High flow nasal cannula therapy group
Patients who will be randomized to high flow nasal cannula therapy. High flow nasal oxygen cannula will be applied at a flow of 20 L/min at FiO2 of 0.4 at a temperature of 36oC.
干预措施: High flow nasal cannula therapy group (Other)
结局指标
主要结局
Oxygen desaturation index
时间窗: During intensive care unit stay (assessed up to day 5)
Oxygen desaturation index will be recorded through by pulse oximeter, while respiratory rate will be recorded by the ECG monitoring and visual count hourly. The number of recorded drops in baseline SpO2 of \>4%.
次要结局
- The incidence of ventilatory support(At the time of intensive care unit discharge (up to day 5))
- The length of Intensive care unit stay(At the time of intensive care unit discharge (up to day 5))
研究者
Omar medhat
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ain Shams University